Personalized Feedback for Cancer Survivor Physical Activity

(Project KNOWN Trial)

Overseen By Yue Liao, MPH, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: The University of Texas at Arlington

Must not be taking: Oral antidiabetics, Insulin

Disqualifiers: Pregnancy, Dialysis, Low-carb diet, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

50 Participants Needed

Trial Summary

What is the purpose of this trial?

This study aims to promote daily physical activity in cancer survivors who are at high risk for type 2 diabetes (T2D) by using a personalized biological-based feedback strategy. T2D is one of the most common co-occurring conditions in cancer survivors and can worsen cancer-related health outcomes, especially in those who are insufficiently active. The investigators hypothesize that seeing the immediate impacts of exercise on their biological status will motivate cancer survivors to exercise. The investigators will use real-time data from continuous glucose monitor to demonstrate the acute impact of physical activity and measure daily activity levels using wearable trackers. As wearable sensor technology is constantly advancing, this study is the first step to exploring how researchers can use wearable sensors to help people make a direct connection between their daily behaviors and health outcomes.

Will I have to stop taking my current medications?

The trial requires that you are not currently taking oral antidiabetic agents or any insulin regimen other than basal insulin. If you are on these medications, you would need to stop them to participate.

What data supports the effectiveness of the treatment Glucose-based biofeedback, Glucose monitoring, Standard feedback for cancer survivors?

Research shows that using wearable devices to provide real-time feedback can significantly increase physical activity in cancer patients, making their activity levels comparable to healthy individuals. Additionally, continuous glucose monitors have demonstrated the immediate positive effects of physical activity on glucose metabolism, which is particularly beneficial for cancer survivors at risk for type 2 diabetes. ^{1 2 3 4 5}

Is personalized feedback for physical activity safe for cancer survivors?

The studies suggest that using wearable devices and personalized feedback to increase physical activity in cancer survivors is generally safe and feasible. These interventions have been shown to motivate behavioral changes without reported safety concerns. ^{1 2 3 4 6}

How does the treatment 'Glucose-based biofeedback' differ from other treatments for increasing physical activity in cancer survivors?

The 'Glucose-based biofeedback' treatment is unique because it uses continuous glucose monitors (CGMs) to provide personalized feedback on how physical activity immediately affects glucose levels, which can motivate cancer survivors to be more active. This approach is particularly relevant for cancer survivors at risk of developing type 2 diabetes, as it directly links physical activity to improvements in glucose metabolism. ^{1 2 3 4 7}

Research Team

Yue Liao, MPH, PhD

Principal Investigator

University of Texas at Arlington

Eligibility Criteria

This trial is for cancer survivors over 18, who've finished treatment at least 3 months ago and are at high risk for type 2 diabetes due to inactivity. Participants must speak English, have a smartphone with internet, and be able to exercise moderately without supervision. Those on certain insulin treatments, other health programs, incompatible smartphones, pregnant women, dialysis patients, overnight workers or those with activity-limiting health issues can't join.

Inclusion Criteria

I can do moderate to hard exercise on my own.

Able to speak, read, and write in English

Have a smartphone with daily internet access

Exclusion Criteria

I do not own a smartphone that works with Fitbit and LibreLink apps.

Currently pregnant

I am currently on dialysis.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a 12-week physical activity intervention with personalized biological feedback

12 weeks

Follow-up

Participants are monitored for changes in physical activity levels and glucose patterns

4 weeks

Treatment Details

Interventions

• Glucose-based biofeedback
• Glucose monitoring
• Standard feedback

Trial Overview The study tests if real-time glucose feedback from wearable devices motivates physical activity in inactive cancer survivors at risk of type 2 diabetes. It compares standard feedback against glucose-based biofeedback using continuous monitors and tracks daily activity levels to see the immediate effects of exercise on biological status.

Participant Groups

Group I: Biofeedback Group Experimental Treatment 1 Intervention

Group II: Standard Care Group Active Control 1 Intervention

Who Is Running the Clinical Trial?

The University of Texas at Arlington

Lead Sponsor

Trials

48

Recruited

7,300+

American Institute for Cancer Research

Collaborator

Trials

12

Recruited

8,600+

Findings from Research

A pilot study will assess the effectiveness of a 12-week physical activity intervention using personalized feedback from continuous glucose monitors (CGMs) to motivate cancer survivors, particularly those at high risk for type 2 diabetes (T2D).

The study aims to explore how daily glucose patterns relate to cancer-related insulin pathways and inflammation, potentially providing insights into the biological mechanisms by which physical activity can benefit cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Using wearable biological sensors to provide personalized feedback to motivate behavioral changes: Study protocol for a randomized controlled physical activity intervention in cancer survivors (Project KNOWN). Liao, Y., Schembre, SM., Brannon, GE., et al.[2022]

A biofeedback device significantly improved physical activity levels in 19 cancer patients, increasing their daily activity counts by 21% and moderate to vigorous physical activity by 9% after receiving real-time visual feedback.

After using the biofeedback device, the physical activity levels of cancer patients became nearly equal to those of 20 age-matched healthy controls, indicating the device's effectiveness in promoting activity in this population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Real-time visual activity feedback for physical activity improvement in breast and colon cancer patients. Gabrys, L., Sperzel, S., Bernhoerster, M., et al.[2019]

Wearable activity monitors, like ActiGraph accelerometers and Fitbits, are generally accepted and effective tools for increasing physical activity levels among cancer survivors, as shown in a review of 28 studies involving both active treatment and post-treatment individuals.

While these devices successfully motivate short-term increases in physical activity, the benefits tend to decrease over time, highlighting the need for further research to enhance the long-term sustainability of these technologies in supporting ongoing physical activity in cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of Wearable Activity-Monitoring Technologies to Promote Physical Activity in Cancer Survivors: Challenges and Opportunities for Improved Cancer Care. Keats, MR., Yu, X., Sweeney Magee, M., et al.[2023]

In a pilot study involving 30 cancer patients, the use of a wearable activity tracker combined with personalized text message feedback led to 39% of participants increasing their daily steps by at least 20% over 3 months.

The intervention was well-received, with 72% of participants continuing to use the activity tracker at least 4 days a week after 6 months, suggesting it may effectively promote physical activity among cancer survivors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). Koontz, BF., Levine, E., McSherry, F., et al.[2022]

A 12-week supervised aerobic exercise program for 15 postmenopausal breast cancer survivors led to significant improvements in fitness and body composition, with participants averaging 156.8 minutes of exercise per week.

While exercise did not significantly change overall insulin resistance measures, it did result in lower insulin levels 120 minutes after glucose consumption, and this effect was notably influenced by the use of aromatase inhibitors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metrics of Diabetes Risk Are Only Minimally Improved by Exercise Training in Postmenopausal Breast Cancer Survivors. Viskochil, R., Blankenship, JM., Makari-Judson, G., et al.[2021]

Breast cancer patients using a wearable activity tracker (WAT) along with counseling showed a significant increase in leisure-time physical activity (LTPA) during radiation therapy, with a relative change of 102.8 compared to 57.8 in the counseling-only group.

The WAT+counseling group also had a notable increase in average daily step counts from 9351.7 to 12,240.1 during and after radiation therapy, indicating that the combination of WAT and counseling is effective in promoting physical activity among these patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparing the Effectiveness of a Wearable Activity Tracker in Addition to Counseling and Counseling Only to Reinforce Leisure-Time Physical Activity among Breast Cancer Patients: A Randomized Controlled Trial. Kong, S., Lee, JK., Kang, D., et al.[2021]

A study of 464 breast cancer survivors found that personal control significantly influences their levels of physical activity after treatment, highlighting the importance of self-efficacy in recovery.

The impact of treatment-related factors and psychological well-being on physical activity varied based on whether the women were working or not, suggesting that tailored interventions should consider individual circumstances and symptoms like fatigue and body image.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treatment-related and psychosocial variables in explaining physical activity in women three weeks to six months post-treatment of breast cancer. Charlier, C., Van Hoof, E., Pauwels, E., et al.[2015]

References

1. United States pubmed.ncbi.nlm.nih.gov

Using wearable biological sensors to provide personalized feedback to motivate behavioral changes: Study protocol for a randomized controlled physical activity intervention in cancer survivors (Project KNOWN). [2022]

2. England pubmed.ncbi.nlm.nih.gov

Real-time visual activity feedback for physical activity improvement in breast and colon cancer patients. [2019]

3. Switzerland pubmed.ncbi.nlm.nih.gov

Use of Wearable Activity-Monitoring Technologies to Promote Physical Activity in Cancer Survivors: Challenges and Opportunities for Improved Cancer Care. [2023]

4. Germany pubmed.ncbi.nlm.nih.gov

Increasing physical activity in Cancer Survivors through a Text-messaging Exercise motivation Program (ICanSTEP). [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Metrics of Diabetes Risk Are Only Minimally Improved by Exercise Training in Postmenopausal Breast Cancer Survivors. [2021]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Comparing the Effectiveness of a Wearable Activity Tracker in Addition to Counseling and Counseling Only to Reinforce Leisure-Time Physical Activity among Breast Cancer Patients: A Randomized Controlled Trial. [2021]

7. Ireland pubmed.ncbi.nlm.nih.gov

Treatment-related and psychosocial variables in explaining physical activity in women three weeks to six months post-treatment of breast cancer. [2015]